Science Day 2017 - Generic drugs in society: the regulator’s dilemma

Trust, costs, safety and proper information are the words that regularly recurred during the 6th Science Day of the Medicines Evaluation Board (MEB) on Friday 3 February. Over 120 interested parties visited the informative afternoon in the Leeuwenbergh in Utrecht.

Einddiscussie op de Wetenschapsdag van het CBG, 3 februari 2017

Patients must be able to trust that the medicines they are getting are effective and safe, but they do not always have that confidence. For example, if their medicinal product has a different packaging, if the tablets suddenly have a different colour or shape, or if the patient information leaflet states something different about the time of day at which they have to be taken. Clear and unambiguous information can take away the patients' distrust. This includes the information in patient information leaflets and on the packaging, but also the information provided by prescribers and pharmacies.

The dilemma

The theme for the day was ‘Generic drugs in society: the regulator’s dilemma’. And there certainly is a dilemma, said Marc Maliepaard (senior assessor at the MEB) when giving the introduction to the subject.

Gabe Sonke, oncologist and MEB member, described how he was told during his first years as a doctor to use generic names when prescribing medicines. Doctors trust the active substance because they know how it works. One striking point in his presentation was the reference to a possible placebo effect when switching to generic medicines: “There is never any discussion about generic medicines that are administered intravenously.” 

The patient

Christine Gispen-de Wied, the chair for the day, interviewed Johan de Graaf, chairman of the Hypofysestichting (Pituitary Gland Foundation) and himself a pituitary patient. In the patients' and consumers' committee, he advises the MEB about aspects that affect patients.

Mr De Graaf explained how complicated the use of medicines can be for patients. Personally, he does have confidence in the effect of generic medicinal products. “Generics aren't an immediate threat; not every patient gets symptoms when they switch to other medicines,” he said. Good information from the pharmacist could immediately eliminate some of the complaints when switching to generic medicines.

Patients would like to be more involved in regulatory science projects. The MEB can play an important role here, for instance by giving information about the results in an understandable way. If patients can find information themselves easily, they will get – or keep – more confidence in generic medicines. 

The researcher

Abby Yu investigated the interchangeability of generic and branded medicines and of different generic medicines. Her conclusions noted that there is very little reason to doubt the bioequivalence of various different medicinal products. According to her there is no reason for concern, although there is room for improvement.

The pharmacist

Thijs Giezen, a hospital pharmacist and chairman of Young MEB, zoomed in on the safety risk for the patient. In 2015, 72.4% of all medicines issued in the Netherlands were generic medicines. At the same time, the costs of generic medicines were 16.5% of the overall costs of medicines.

Mr Giezen listed various examples where things can go wrong when a patient switches between generic and branded medicines, for example because the packaging is different, the method of administration differs or a suspension is given instead of a solution. In the latter case, it is important that the medicine is shaken before use. If not, there is a risk of underdosing early in the treatment and overdosing at the end, because the active ingredient sinks to the bottom.

Quality of medicine use

It was mentioned regularly during the day: the importance of good communication about the use of medicines. Petra Denig, professor of Quality of Medicinal Product Use at UMC Groningen, finished the lectures on the Science Day with a talk about ‘Improving (risk) communication for the prescriber and user’.

Studies by the Netherlands Institute for Health Services Research (NIVEL) show that more than half of all patients do sometimes look up information about medicines. It is important to them that they can trust the source and that the information is understandable and up to date, as well as being clear how well it fits with their own situation. Ms Denig noted that the information about medicines often does not give details about the number of patients who benefit from the medicine. “If you want to reach patients, use sources that they trust,” concluded Ms Denig.

You can find the interview with Petra Denig and Christine Gispen-de Wied in the new Regulatory Science Magazine